No registrations found.
ID
Source
Brief title
Health condition
helium
coronary circulation
coronary vessel diameter
coronary micro vascular resistance
Sponsors and support
Intervention
Outcome measures
Primary outcome
Coronary flow reserve (CFR) in the LAD.
Secondary outcome
1. Fractional flow reserve (FFR) in the LAD;
2. MR in the LAD;
3. Lumen diameter of the RCx;
4. Vessel diameter of the RCx;
5. CFR in the RCx;
6. FFR in the RCx;
7. MR in the RCx;
8. Collateral flow index (CFI);
9. Global hemodynamic parameters during helium application;
10. Complications during and following PCI.
Background summary
In animal models of myocardial infarction, helium pre- and postconditioning has shown promising results in the reduction of infarct size. Since helium , which is a registered medical gas, has no cardiovascular side-effects known until now, it could provide an attractive therapeutic agent to reduce ischemia reperfusion injury in clinical settings of ischemia-reperfusion, e.g. acute myocardial infarction. It appears that helium has no effects on hemodynamics. However, whether helium has any effect on the coronary circulation is not known. This study investigates whether helium influences coronary flow, coronary pressure, microvascular resistance and vessel diameter of coronary arteries in humans. The study is an open-label single center study with a cross-over design, in which 20 patients scheduled for elective PCI of the LAD will be included. In all the participants measurements will be done before and after helium inhalation (79% helium with 21% oxygen).
Study objective
Helium inhalation influences the coronary circulation and/or vessel diameter.
Study design
Before and after helium inhalation.
Intervention
During PCI, participants will breathe helium 79% during 10 minutes. Measurements will be done both before and after helium inhalation.
Daniel Brevoord
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
d.brevoord@amc.nl
Daniel Brevoord
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
d.brevoord@amc.nl
Inclusion criteria
1. Elective Percutaneous coronary intervention (PCI) of the left anterior descending artery (LAD);
2. Age >18 years;
3. Written informed consent.
Exclusion criteria
1. Acute coronary syndrome;
2. Cardiogenic shock;
3. Prior coronary artery bypass grafting (CABG);
4. Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis);
5. Diffuse disease;
6. Diabetes;
7. Severe pulmonary disease;
8. Kidney failure (clearance <30 ml/min);
9. Liver failure;
10. Prior revascularisation;
11. Consecutive stenoses in a single artery;
12. Expected inability to complete the study protocol;
13. Participation in another study using ionizing radiation within the last year;
14. Employed in a profession using ionizing radiation;
15. Use of a non-selective betablokker.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2396 |
| NTR-old | NTR2504 |
| Other | METC AMC : 09/328 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |